Kornimate/medical-research-clean huggingface dataset:
cytomegalovirus (cmv) infection in amniotic fluid

Conditions: Pregnancy Complications; Cytomegalovirus Infections

Summary: the purpose of this study is to determine if detection of cytomegalovirus (cmv) in amniotic fluid collected in the second trimester of pregnancy is associated with pregnancy complications such as preterm delivery or severe preeclampsia.

cmv infection in adults with a normal immune system is rarely a serious event. once a person has been infected with cmv, they may have recurrences (relapses) of the infection. if a mother is infected with the virus or relapses during pregnancy, her fetus may be at risk for infection. unlike infection in adults, congenital infection may result in serious complications (congenital infection). the effects of fetal infection with cmv are well understood and many efforts have been made to potentially reduce the risk of congenital infection. however, the effect of cmv infection on the pregnancy itself (when the fetus is not affected by cmv) is less understood. the incidence of cmv detection in amniotic fluid collected in the second trimester is thought to be low. however, the association between detection of cmv infection in the second trimester and ultimate pregnancy outcome is poorly described. in this study, we plan to determine if cmv detection in amniotic fluid collected in the second trimester is associated with pregnancy complications.

Eligibility criteria:
inclusion criteria: * women who deliver at term without pregnancy complications * women who deliver (preterm, less than 37 weeks of gestation) as a result of spontaneous preterm labor * women whose pregnancies are complicated by severe preeclampsia exclusion criteria: * women with multi-gestational pregnancies, or whose pregnancies are complicated by a congenital malformation or chromosomal abnormality * women who have a medical history of hypertension (high blood pressure), diabetes, or severe renal (kidney) disease

Keywords: pregnancy cytomegalovirus
a remote, decentralized opioid use disorder study to evaluate patient engagement with a game-based digital therapeutic

Conditions: Opioid-use Disorder

Summary: the purpose of this study is to evaluate how patients use and engage with a game-based mobile application that is designed to treat opioid use disorder.

this is a randomized, controlled, open-label, decentralized study to evaluate patient engagement with pear-008, a game-based digital therapeutic for the treatment of opioid use disorder. pear-008 is a new version of reset-o, an fda-authorized mobile application treatment (available by prescription only) for opioid use disorder. the study will examine if changing the application's delivery format and enhancing clinical content affects how patients use and interact with the intervention. prospective participants will complete a short screening assessment and if eligible complete informed consent procedures at the beginning of the baseline visit. qualifying participants will attend weekly virtual study visits during the 8-week treatment period. in addition to weekly assessments, additional assessments will be administered at week 4 and week 8. participants will be asked to complete a follow-up assessment 4 weeks after completing treatment.

Eligibility criteria:
inclusion criteria: * provide informed consent prior to any study specific assessments being performed * between 18 and 60 years old, inclusively * proficient in english language * within the first 120 days of starting buprenorphine treatment * receiving buprenorphine pharmacotherapy under the care of a licensed healthcare provider and willing to provide the provider or practice name * capable of using common software applications on a mobile device (smartphone) * access to an internet-enabled smartphone for the duration of the study, meeting minimal operations systems (os) requirements * interest in using a digital therapeutic for opioid-use disorder * no prior history of reset-o use * has not participated in user testing of pear-008 or any investigational drug trials within the past 30 days of enrollment exclusion criteria: * on methadone or naltrexone pharmacotherapy * unable to use english to participate in the consent process, interventions, or assessments * inability to comply with study procedures

Keywords: digital therapeutic
power training in older multiple sclerosis patients

Conditions: Multiple Sclerosis; Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Healthy Aging; Aging

Summary: the study seeks to investigate whether 24 weeks of power training has neuroprotective effects in older pwms. additional purposes are to examine the effects of 24 weeks power training on physical function, cognitive function and neuromuscular function. further, it is investigated whether the potential effects of power training are maintained after 24 weeks of follow-up.

over the past 3-4 decades, the lifespan among people with multiple sclerosis (ms) has increased substantially. today more than one-third of all people with ms are 60 years or older. with advanced age, people with ms are more likely to have impairments in cognitive and physical function. positive adaptations within the nervous system (\~neuroplasticity) have been shown to occur in people with ms following periods of resistance training (rt). this resembles the observations in young and old healthy individuals. moreover, a specific type of rt termed power training appears to be particularly beneficial, as it emphasizes an explosive concentric phase of muscle contraction. this taxes the nervous system to a very high extent. as a result, power training has been shown to improve several aspects that rely on the nervous system in older individuals without ms. these aspects include cognition, neuromuscular function, and physical function. the investigators speculate that older people with ms would also benefit. however, no studies have looked into the effects of power training in older people with ms.

Eligibility criteria:
inclusion criteria: * ≥ 60 years of age. * clinically diagnosed with ms according to the mcdonald criteria (48). * having an edss ≤ 6.5. * able to transport themselves to the testing at aarhus university and aarhus university hospital. * able to transport themselves to training, if randomized to the prp group. exclusion criteria: * having comorbidities (cardiovascular, respiratory, orthopedic, or other neurological diseases than ms) affecting prp participation or mri scans. * having a pacemaker. * having metallic implant(s) that prevents mri scans. * having untreated osteoporosis; t-score below -2.5 and a history of low energy facture or t-score below -3.0. * participating in more than two sessions per week of structured pre and have done so for the past 3 months. * are cognitively impaired at a level expected to prevent the participant from understanding training and testing instructions.

Keywords: multiple sclerosis healthy aging exercise neuroprotection
safety study of hbv-002 west nile vaccine in healthy adults

Conditions: West Nile Virus Disease

Summary: the purpose of this phase 1 trial is to evaluate the clinical safety of hbv-002 vaccine in healthy adults.

west nile virus is an emerging infectious disease in the u.s. and worldwide and has been identified by the cdc as a significant public health risk. since the introduction of west nile virus into the u.s. in 1999, annual outbreaks have caused severe and fatal encephalitis in humans and equines and death in a variety of species of feral birds throughout the u.s. and parts of canada. in addition, more recent findings show evidence of west nile virus human and equine infection in several countries of tropical america. the virus has now been found in bird populations in all 48 states of the continental u.s, and human cases of west nile disease have been documented in 45 states and the district of columbia. to date, there is no approved commercial vaccine available for prevention of west nile virus disease in humans.

Eligibility criteria:
inclusion criteria: * satisfactory medical assessment with no clinically significant and relevant abnormalities (medical history, physical examination, vital signs, ecg, clinical laboratory evaluation \[hematology, biochemistry, urinalysis\]) * body weight must not be more than 10% below of 20% above the ideal weight for height and frame size according to the 1999 metropolitan life table exclusion criteria: * current active infection process including uri or influenza * positive serum test for hiv, hepatitis b surface antigens and/or hepatitis c antibodies * history of infection with, or serologic evidence in screening test, of prior flavivirus infection (to include viruses: west nile, 4 dengue serotypes, yellow fever (yf), and japanese encephalitis (je) * subject has resided in flavivirus (west nile, 4 dengue serotypes, yf, and je) endemic areas or has a history of receipt of yellow fever or japanese encephalitis virus vaccines * history of alcohol or other substance abuse within 1 year of screening * use of corticosteroids or immunosuppressive drugs within 30 days of screening (use of topical or nasal corticosteroids are not excluded.) * any confirmed or suspected immunosuppressive or immunodeficient condition * administration of immunoglobulins within three months of the first vaccination or planned during the study period * receipt of any vaccines or investigational or non-registered product other than hbv-002 within 30 days prior to screening or planned receipt throughout the study. * receipt of another study vaccines within 30 days prior to screening * receipt of blood products within 6 months of screening

Keywords: west nile virus west nile vaccine west nile virus disease hawaii biotech
comparison of eldoa and mechanical traction technique on pain and disability in patients with lumbar disc herniation

Conditions: Lumbar Disc Herniation

Summary: to compare the effect of eldoa and mechanical traction technique on pain in patients with lumbar disc herniation. to compare the effect of eldoa and mechanical traction technique on disability in patients with lumbar disc herniation.


Eligibility criteria:
inclusion criteria: * age: 20-65 years * both gender male \& female * patients having lumbar radiculopathy diagnosed with lumbar disc herniation. exclusion criteria: * patients presented with motor deficit, * qauda equina syndrome, * lumbar fracture * spinal stenosis, * osteophyte formation * facet joint pathology * spondylolisthesis. * malignancy, * degenerative disorders * recent back surgery and patient whom surgery for lumbar disc herniation/prolapse intervertebral disc already advised by neurosurgeon
prospective long-term evaluation of the efficacy and safety of calistar s for transvaginal pelvic organ prolapse repair

Conditions: Pelvic Organ Prolapse

Summary: prospective long-term evaluation of the performance and safety of calistar s for transvaginal pelvic organ prolapse repair in women with anterior pop with or without apical vaginal involvement

calistar s single incision pelvic organ prolapse (pop) repair system is intended for transvaginal reestablishment and reinforcement of the physiologic anatomy of the female pelvic floor in non-fertile women with anterior pelvic organ prolapse with or without apical vaginal wall involvement in both, recurrent pelvic organ prolapse and primary pelvic organ prolapse when other surgical procedures are expected to fail (i.e. complex primary prolapse). the treatment kit consists of the lightweight mesh, two single-use introducers and 3 tissue anchoring system (tas) anchors for fixation to the sacrospinous ligament. the product is approved in accordance with the ce directive 93/42/eec. the utilization of synthetic implants in pop repair became increasingly popular in the last decade. the cumulative success rate of synthetic implants in anterior compartment repair is as high as up to 93%.however, meshes have been recently scrutinized due to high adverse event reporting after unreflected utilization of meshes which raised concerns of patients safety; furthermore taking into account the complexity of adverse event mesh management. this led to a vanishing of various meshes in transvaginal pop repair. nevertheless, the further development of light weight meshes, the experience of the surgeon and the assessment and patients selection are well known factors reducing the rate of adverse events significantly. therefore, in the current trial the efficacy and safety of calistar s in a highly selected patient population will be evaluated.

Eligibility criteria:
inclusion criteria non-fertile women \> 18 years1 2. symtomatic anterior prolapse with or without apical vaginal wall involvement according pop-q score ≥ 2. (corresponding to aa, ba ≥ -1 and where applicable c ≥ -1/2 tvl ). 3. subjects with recurrent prolapse or complex primary prolapse are eligible for the study. 4. scheduled mesh-augmented anterior pop repair with calistar s 5. signed inform consent exclusion criteria 1. fertile women 2. patients with active or latent infection of the vagina, cervix or uterus 3. patients with previous or current vaginal, cervical or uterine cancer 4. previous, current or planned pelvic radiation therapy 5. known allergy to polypropylene 7. subject is unable or unwilling to complete questionnaires (either self-administered, assisted or interviewed) and/or to follow scheduled visits and/or to sign informed consent

Keywords: surgical mesh surgery therapy pelvic floor disorders cystocele
to evaluate the safety, tolerability, pulmonary deposition, pharmacokinetics and pharmacodynamics of ciprofloxacin inhale in japanese patients with moderate to severe chronic obstructive pulmonary disease (copd, gold ii-iii)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the study will be conducted in a single-center, randomized, single-blinded, placebo-controlled, dose escalation design with two dose groups.multiple-dose inhalation of ciprofloxacin inhale 50 and 75 mg or placebo will be administered to 16 japanese patients with copd in totalpatients with moderate to severe copd, stage ii or iii according to gold criteria, will participate in the study.the study will consist of 2 steps as indicated below; starting at step 1 (50 mg) and escalating doses up to step 2 (75 mg), after the tolerability of the dose in the previous step is confirmed. in each step, the study will be conducted as multiple dose study with b.i.d. regimen for 10 days (between day 2 and 11) in a randomized, single-blind, placebo-controlled design. in addition, before and after the multiple dose administration, single administration will be conducted in each subject (day 0 and 12).


Eligibility criteria:
inclusion criteria: * adult patients with copd, 40 to 80 years of age * all patients must have a diagnosis of copd and must meet the following spirometric criteria: patients must have relatively stable airway obstruction with a post-bronchodilator 30% \</= forced expiratory volume (fev1) \</= 65% of predicted normal. and a post-bronchodilator fev1 / forced vital capacity (fvc) \<70%. exclusion criteria: * patients with a significant respiratory disease other than copd. a significant disease is defined as a disease which, in the opinion of the investigator * patients with a medical disorder, condition or history of such that would impair the patients ability to participate or complete this study in the opinion of the investigator, patients who have mental disorder which is inappropriate to communal living in a participation in a clinical study, who have no ability to give informed consent, or who have physical disability * patients with a history of cf * patients with clinically evident bronchiectasis * patients with a history of asthma * patients who have undergone thoracotomy with pulmonary resection * patients with relevant conspicuous findings in medical history and pre-study examination not related to the underlying disease

Keywords: chronic obstructive phase i pharmacokinetics microbiology
a study to evaluate the safety and efficacy of zoledronic acid in the prevention or delaying of bone metastasis in patients with stage iiia and iiib non-small cell lung cancer (nsclc)

Conditions: Non-Small-Cell Lung Cancer

Summary: 30-40% of patients with lung cancer will develop bone metastases during the course of their disease, which can lead to pain, decreased mobility and skeletal complications. this study will investigate the effect of zoledronic acid on preventing or delaying the development of bone metastases and the impact on disease progression/survival in patients with stage iiia and iiib non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed non-small cell lung cancer (nsclc) * newly diagnosed, stage iiia and stage iiib excluding patients with pleural effusion * patients must have received primary treatment for their disease and had no progression exclusion criteria: * diagnosed with nsclc longer than 6 months ago * treatment with other bisphosphonates in past 12 months * presence of metastases other protocol-defined inclusion and exclusion criteria may apply.

Keywords: non-small-cell lung cancer bisphosphonates zoledronic acid bone metastases prevention of bone metastases
an inpatient study of alln-346 (engineered urate oxidase) in hyperuricemic subjects (study 201)

Conditions: Hyperuricemia; Gout; Chronic Kidney Diseases

Summary: the purpose of this phase iia study is to evaluate the safety and tolerability of alln-346 in subjects with hyperuricemia in an inpatient, controlled setting.

this is a phase ii, 7-day, randomized, double-blind, placebo-controlled study of orally administered alln-346 in subjects with hyperuricemia, with subpopulations to include generally healthy hyperuricemic subjects with normal kidney function and those with mild to moderate chronic kidney disease (ckd). study will take place at a clinical pharmacology unit (cpu). the study will have two parts. part 1 will include subjects with serum urate ≥ 6.8 mg/dl and egfr ≥ 60 ml/minute/1.73 m2 (subjects with egfr of stage 2 ckd and with normal kidney function). part 2 will include subjects with serum urate ≥ 6.8 mg/dl and egfr 45-100 ml/minute/1.73 m2 (egfr of ckd stages 2- 3a). the study will evaluate safety, tolerability, pharmacokinetics (lack of absorption) and pharmacodynamics of alln-346.

Eligibility criteria:
inclusion criteria: * male or female, age 18 to 55 years * sua level ≥ 6.8 mg/dl at screening (hyperuricemia), with or without a diagnosis of gout * not pregnant, not capable of pregnancy, not nursing, and agrees to use an effective method of contraception; males subjects must agree to abstain from sperm donation * normal non-clinically significant abnormalities in vital signs * normal clinical laboratory test results and ecg, which are not considered to be clinically significant exclusion criteria: * screening egfr of \<60 ml/minute/1.73 m2 for part 1, and for part 2 screening egfr outside the range of 45-100 ml/minute/1.73 m2. * history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, urological, or psychiatric disorders. * presence or history of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines * currently taking any urate-lowering medication within 4 weeks prior to day 1 (first dosing day) * prior uricase therapy or exposure to recombinant uricase * clinically significant abnormal findings on electrocardiogram (ecg) * positive test result for hepatitis b surface antigen, hepatitis c virus antibody, or human immunodeficiency virus (hiv) antibody * received treatment with or exposure to an investigational drug or device within 30 days - prior to or during screening * prior dosing in alln-346 clinical study * per investigator judgment, is not an ideal clinical study candidate
a personalized video-based exercise program for fall prevention in frail and pre-frail older adult

Conditions: Fall Injury; Frailty; Old Age; Atrophy; Age-Related Atrophy; Age-Related Sarcopenia

Summary: this is a randomized interventional clinical trial, whereby 100 participants will be randomized to either follow the safe exercise program (experimental group) or not (control group). at the end of the intervention, the experimental group will be encouraged to continue doing the exercises, and the control group will have the opportunity to participate in the safe exercises. 12 weeks post-intervention, the investigators will follow up with participants by telephone to follow up whether they are still following the safe program or not.

for this study, the investigators will recruit 100 frail men and women aged 75 and over from the greater montreal area. enrolled participants will have 4 visits at their residence. the first visit, is a screening visit, the second is a pre-intervention assessment of cognition and functional abilities and explanation of the exercise program. the third visit will be a virtual visit, by phone call, and the final visit will be a post-intervention assessment of cognition and functional abilities. participants in the experimental group will engage in the safe exercises three times a week for 12 weeks at home while continuing their activities of daily living (adls) without any changes. participants in the control group will not engage in the safe exercises but will be asked to maintain their adls without any changes. before and after the 12-week intervention, all participants will complete a comprehensive battery of assessments to evaluate changes in their muscular strength, functional capacities, cognitive abilities and quality of life. at the end of the intervention, the experimental group will be encouraged to continue doing the exercises, and the control group will have the opportunity to participate in the safe exercises. 12 weeks post-intervention, the investigators will follow up with participants by telephone to follow up whether they are still following the safe program or not.

Eligibility criteria:
inclusion criteria: * considered frail or pre frail according to fried's criteria exclusion criteria: * smoked within 6 months prior to study enrollment, * dementia diagnosos, * abused drugs, medication or alcohol within up to 30 days prior to the start of the study. * drug or alcohol-addiction, * heart disease, history of heart attacks or electrocardiogram abnormalities * any family history of thrombosis, thrombosis risk, * hypocalcaemia, * uric acidemia, * orthostatic intolerance, * vestibular disorders, * considerable musculoskeletal issues, * chronic back pain, * head trauma, * seizures, * ulcers, * renal stones, * gastro-esophageal reflux disease, * renal function disorder, * hiatus hernia, * migraines, * mental illness diagnosis * prescribed medication that may interfere with the interpretation of the results

Keywords: frailty exercise older adult ageing